The second CE Mark has been awarded to MedAlliance for the new Sirolimus Drug Eluting Balloon (DEB), SELUTION SLR 014 PCTA. This is used to treat coronary arterial disease. This is indicative for both in-stent restenosis and de-novo lesions. A wide gamut of balloon sizes from 1.5 x 10 mm up to 5.0 x 40 mm have been approved.
The SELUTION SLR First-in-Human study had one-year results involving six Indian centers and 56 patients, which led to this award. Of these, 12.4% had in-stent restenosis (ISR) lesions, 87.6% of patients had de-novo lesions, and 46.6% of whom had diabetes.
The main aim of the study was achieved in case of 100 percent patients, which was freedom from device and procedure-related mortality. Up to 30 days, no Major Adverse Cardiovascular Events (MACE) was reported and a singular case occurred upto one year. The efficacy and safety of SELUTION SLR was similar to a drug-eluting stent (DES). Only one patient needed a Target Lesion Revascularization (TLR). This one TLR case caused the low overall MACE rate of 2 percent in a year.
The efficacy, safety, and optimal performance of SELUTION SLR in coronary applications is endorsed by Co-Principal Investigators Dr. Shirish (MS) Hiremath (Director of Cath Lab and Consultant Cardiologist, Ruby Hall Clinic) and Dr. Praveen Chandra (Chairman – Department of Interventional Cardiology, Medanta- The Medicity).
For many years, DES is the main treatment of CAD. However, side branches, bifurcation, long lesion and small vessel, and instant re-stenosis have been specifically a challenge. The LIMUS DEB (SELUTION) is used to offer alternative treatment modality and also completely heal without leaving nothing behind.
In February 2020, the CE Mark approval was given to MedAlliance for SELUTION SLR to treat peripheral artery disease. The company had just completed its below-the-knee (BTK) First-in-Human study in Singapore. In April, the first patient was enrolled in the SAVE study in Arterial Venus Fistula (AVF). In this quarter, enrollment will begin for the STEP Pedal Arch study. This will be followed by a 500-patient post-marketing clinical study. Later this quarter, the US IDE ISR study will begin.
Globally, MedAlliance is the first DEB company to get US Food and Drug Administration (FDA) Breakthrough Device Designation Status for a coronary DEB. Now, SELUTION SLR has this status for several indications: peripheral below-the-knee lesions, coronary in-stent restenosis, the treatment of AV-Fistula.
The technology of SELUTION SLR consists of unique microreservoirs from the biodegradable polymer mixed with the anti-restenotic drug siromilus. Microreservoirs cause controlled, sustained drug release. In both coronary and peripheral vasculatures, extended release of sirolimus from stents is proved to be highly efficacious. MedAlliance has the proprietary CAT technology to enable the microreservoirs to be balloon-coated and adhered to the vessel lumen after delivery from an angioplasty balloon.
We are excited with the new technology in Limus DEB SELUTION SLR
Dr. M.S Hiremath
Director of Cath Lab and Consultant Cardiologist, Ruby Hall Clinic
"I am extremely pleased with the CE Mark approval of this innovative technology," added Dr. Chandra. "Small vessels and ISR are challenges for existing DES and DEB technologies, but this exciting new tool of a limus-eluting balloon can truly address the coronary conundrum of leaving nothing behind in the coronary artery, for complete healing."
"We are very excited to have been awarded our second CE Mark, which is testament to the documented efficacy and safety of our novel sustained-release limus-eluting balloon in the treatment of coronary applications," concluded MedAlliance Chairman and CEO Jeffrey B. Jump. "SELUTION SLR is designed to deliver the same safety and performance as best-in-class DES technology with the added benefit of leaving nothing behind."
For more details, visit www.medalliance.com
